NEW TREATMENT OPTION APPROVED FOR LENNOX-GASTAUT SYNDROME, ONE OF THE MOST DEBILITATING FORMS OF EPILEPSY

Ortho-McNeil Pharmaceutical Receives New Indication for Topamax(r) (topiramate)

Raritan, NJ - September 4, 2001 - Adults and children (age 2-16) who suffer from seizures associated with Lennox-Gastaut Syndrome - a severe, debilitating form of epilepsy - now have a much-needed new treatment option with the announcement today that the U.S. Food and Drug Administration has approved Topamax(r) (topiramate) tablets and sprinkle capsules as an adjunctive (add-on) treatment for this condition.

Lennox-Gastaut Syndrome (LGS) is one of the most severe forms of epilepsy. Individuals who suffer from this illness experience dozens of seizures a day, many of which are resistant to most anti-epileptic drugs. In some cases, LGS seizures are fatal. The condition typically first occurs in early childhood and accounts for up to 10 percent of all cases of pediatric epilepsy.

"Lennox-Gastaut is a devastating form of epilepsy, particularly for children. Patients are often developmentally delayed and suffer seizures that are severe, very tough to control and may even lead to injuries," says Tracy Glauser, MD, director of the Children's Comprehensive Epilepsy Program at Cincinnati Hospital Medical Center and a member of the professional advisory board of the Epilepsy Foundation of America. "Until now, anti-epileptic drugs have either not been effective for Lennox-Gastaut, or have had significant side effects, so topiramate offers hope for children and adults with this disease."

MYSTERIOUS CONDITION; SERIOUS IMPACT

Epileptic seizures are abnormal electrical discharges in the brain that temporarily disrupt normal brain function. Seizures are either classified as "generalized," when the abnormal discharge affects both sides of the brain simultaneously, or "partial," when the discharge affects just one side of the brain. Patients with Lennox-Gastaut Syndrome may experience both generalized and partial seizures.

A significant number of patients with Lennox-Gastaut Syndrome are mentally retarded, and/or suffer from developmental delays and behavioral disturbances. The cause of LGS is unknown, although some cases are believed to result from brain injury, malformation or infection. Some evidence suggests that hereditary factors also may play a role in the syndrome's development. There is currently no cure.

CLINICAL DATA AND EXPERIENCE

A study of Topamax was conducted at 12 sites, involving 98 patients who had a history of symptoms associated with Lennox-Gastaut Syndrome and had experienced a minimum of 60 seizures during the month before the study started. Patients continued to receive any previously-prescribed anti-epileptic drugs and were randomized to receive either Topamax or placebo as adjunctive medication.

"The results of the study of topiramate in Lennox-Gastaut Syndrome are impressive, given how difficult this condition can be to treat - particularly in young children," says John Pellock, MD, chairman of child neurology at the Medical College of Virginia and one of the investigators in the study. "The evidence suggests that topiramate will be a valuable addition to our arsenal against this serious condition."

The 11-week, double-blinded portion of the study showed that Topamax - when used in combination with one or two other anti-epileptic drugs - can significantly reduce both the severity of seizures and the number of "drop attacks" (serious seizures characterized by complete loss of muscle tone and sudden falls). During the study, 52 percent of family members caring for individuals who received Topamax reported that seizures had improved overall, compared to 28 percent of caregivers of patients receiving placebo.

Overall, in clinical trials in which Topamax was combined with traditional anti-epileptic drugs, the most common side effects observed in children included excessive drowsiness, loss of appetite, fatigue, nervousness, difficulty with concentration/attention, weight loss, aggressive reaction and memory difficulties. Safety and effectiveness in patients younger than two have not been established. In adults, the most common types of side effects were sleepiness, dizziness, poor coordination, speech difficulties, slowed thinking (psychomotor slowing), blurred or double vision, memory difficulties and changes in sensation. However, these effects were generally temporary.

Topamax is available in tablets and in capsules that can be opened and sprinkled onto food for easy swallowing. The capsules also can be swallowed whole, offering patients greater flexibility.

PRODUCT BACKGROUND

Topamax is marketed under various brand names in more than 75 countries and to date, has been used to treat seizures in approximately 825,000 patients worldwide. The FDA first approved Topamax in 1996 as add-on treatment for adults with partial-onset seizures. In July 1999, the drug was the first "new-generation" anti-epileptic drug to be approved to treat partial-onset seizures as adjunctive therapy in children as young as two years old. In October of 1999, Topamax also was approved as add-on treatment for primary, generalized "tonic-clonic" seizures (in which a temporary loss of consciousness and muscle control occurs) in adults and children aged 2-16.

Topamax was discovered and developed by the R.W. Johnson Pharmaceutical Research Institute, and is marketed in the United States by Ortho-McNeil Pharmaceutical, a Johnson & Johnson company. Based in Raritan, NJ, Ortho-McNeil markets pharmaceutical products in several therapeutic categories, including central nervous system disorders, infectious diseases, wound healing and women's health.

For more information, please read the full U.S. prescribing information, available upon request by calling 1-800-682-6532 or by visiting www.topamax.com or www.ortho-mcneil.com.

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CONTACTS:Pam Rasmussen (609) 730-2986 [email protected]Michelle Kirsche/Michael Lampe (201) 585-9911 [email protected] http://www.topamax.com/lgs

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